Senior QA Specialist Material

4 maanden geleden

Geleen, Nederland Lonza Voltijd

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science,there’sno magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. Andthat’sthe kind of work we want to be part of.

Senior QA Specialist Material & Supplier interacts directly with Lonza’s internal and external stakeholdersto provide Quality oversight of the materialand supplier management process on site.

He/she ensures compliance withGood Manufacturing Practices(GMP) regulations for implementation of raw materials and services used in manufacturing and supporting areas,reviews and approves documentsrequired for material assessment and setup, ensures supplier/service provider qualification, and provides compliance knowledge to support resolution of material release issues and other relevantQuality events.

As an established Subject Matter Expert (SME), he/she provides resolution to escalated issues within their area of responsibility and helps define the strategy for improvements efforts. 

Key responsibilities:

Provide Quality oversight required to on-board materials on site:

Review and approve raw material lists and material assessments, including relevant supply chain information.

Review and approve material specifications.

Review and approve material setup in SAP.

Participate in cross-functional meetings and actively contribute to facilitate material setup process.

Provide Quality oversight of the site supplier/service provider qualification:

Identify correct classification of materials, services, and tier required for suppliers/service providers qualification.

Review and approve SSPAR.

Initiate and manage supplier qualification process.

Perform supplier qualification and/or closely work with Global Lonza supplier qualification functions in order to facilitate supplier qualification process.

Facilitate supplier complaints management.

Facilitate vendor change notifications management.

Provide QA support, review and approval for all relevant Quality events (Deviation, Change Control, and CAPA).

Update and revise relevant SOPs required to ensure compliance in area of expertise.

Contribute to continuous improvement for topics related to material assessments, setup and supplier/service provider qualification process.

Keep up to date with compliance and regulation guidelines within the industry, and support day-to-day compliance activities in accordance with approved procedures and policies on site.

He/she requires little direction and coaching for day-to-day activities, and is expected to be SME to the associated workflows.

Key requirements:

Bachelor B.Sc. (Master is possible as well)

Related experience 2-7 years

Flexibility, work must be finished. 

Planning can change quickly, dynamical environment.

English language proficiency

Documentation GDP (GMP).

QMS knowledge

SAP knowledge, subsystem use

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. Howwe achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developingnew ideasin life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R61959

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